Ensuring Medical Device Industry Quality System Standards Compliance

摘要

Success in the highly competitive medical device industry demands developing the right device first, on time and within budget. International and country-specific quality standards must be met to sell Class II (e.g. an external monitoring device) and III devices (e.g., a long-term implantable device), devices containing software, as well as selected Class I devices (e.g., surgeon's gloves). This paper discusses how proven requirements management practices such as traceability, change management, user definable views into project data, simultaneous access to information and the use of electronic records can save time and money, while ensuring compliance as a side benefit. Focus is on quality standards having the greatest impact on the medical device commercial marketplace: FDA's Quality System Regulation, ISO 13485 Quality System Standard and the CE Mark for the European Economic Community.